Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections
Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.
2 products
Sterility failure recalls
Recalls flagged for sterility failure, newest first. 106 recalls
1 recall
2 recalls
SI-BONE iFuse TORQ Implant System
The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.
Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts
Grafton DBM and Grafton Plus DBM may cause infection if implanted.
2 recalls
Apothecary Pharma NAD+ and Tirzepatide Injections
Tirzepatide Injection lacks assurance of sterility.
2 products
Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables
Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack assurance of sterility.
16 products
2 recalls
K.C. Pharmaceuticals Eye Drops
Artificial Tears Sterile Lubricant Eye Drops lack assurance of sterility.
8 products
Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter
The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.
1 recall
PHP Animal Health Pet Drops Lubricant Eye Drops
PHP Animal Health Pet Drops Lubricant Eye Drops lack assurance of sterility.
1 recall
FOCUS PI Hypromellose 0.7% Formula
FOCUS PI Hypromellose 0.7% Formula lacks assurance of sterility.
2 recalls
Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
2 products
Merit Medical Embosphere Microspheres
Embosphere syringes may have holes in packaging that could affect the sterile barrier and lead to infection.
1 recall
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops
Clear Eyes Redness Relief eye drops lack assurance of sterility.
2 products
1 recall
Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lacks assurance of sterility.
9 products
1 recall
Hospira Dopamine HCl Injection
Dopamine HCl injection lacks assurance of sterility.
3 recalls
Halyard Medical Trays
Haylard 18G Single Shot EPI Tray may have quality and sterility issues.
4 products
Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery
Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.
4 products
Medical Action Blood Culture Collection Kits
Blood culture collection kits contain an applicator with an open or incomplete seal that may compromise sterility and lead to infection.
1 recall
American National Red Cross Apheresis Plasma
Apheresis PF24RT24 Plasma was collected in a manner that compromises the sterility of the collection system.
3 recalls
Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections
Glutathione, Myer's Cocktail, and Tri-Immune Boost injectable vials may contain elevated endotoxin levels, which could cause significant medical events.
3 products
Maquet Percutaneous Insertion Kits and Guidewires
The packaging may not consistently maintain sterile barrier integrity.
3 products
Medline Open Heart A Pack Convenience Kit
The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection.
1 recall
Medical Action Industries Epidural Kits
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
2 products
1 recall
AVID Medical Halyard IV Start Kits
The Halyard IV Start Kit lacks sterility assurance due to wrinkles in the paper lidding that may breach the seal area.
1 recall
American Regent Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility.
1 recall
Medline Convenience Kits
Medline Convenience Kits contain applicators with a potential breach of sterility in the packaging.
16 products
1 recall
Halyard Medical Convenience Kits
Halyard medical convenience kits may contain neurological sponges with unexpected variability of endotoxin levels.
3 products1 recall
American Contract Systems Medical Procedure Kits and Trays
Medical procedure kits and trays may have unexpected variability of endotoxin levels on included sponges.
2 products1 recall
Optimal Balance Pharmacy Glutathione Injection
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
2 recalls
Libtayo (Cemiplimab-Rwlc) Injection
Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.
Arrowhead DE Arrow-LOK Implant
The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.
2 recalls
CLEAR EYES Maximum Itchy Eye Relief
CLEAR EYES Maximum Itchy Eye Relief lacks assurance of sterility and may be contaminated.
BD Intravascular Administration and Extension Sets
Intravascular administration sets may not have received adequate sterilization processing.
1 recall
Spectra Medical Devices Sodium Chloride Injection
Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.
1 recall
Covidien V-Loc, Dermalon and Surgipro Wound Closure Devices
V-Loc 90 Absorbable Wound Closure Device may have a perforation or tear in its sterile barrier packaging, which may lead to infection or prolonged surgery.
5 products
1 recall
Victory Medical Center Pharmacy Glutathione Injection
Compounded glutathione vials have elevated bacterial endotoxin levels, which could cause fever, hypotension, inflammatory reactions, anaphylactic shock.
1 recall
Zimmer Biomet Intramedullary Bone Saw Blade Assembly
The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.
5 products
1 recall
Boston Scientific Radial Jaw 4 Biopsy Forceps
Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.
3 products
1 recall
AMS Aligned Medical Solutions Surgical Procedure Packs
Medical convenience kits contain neurological sponges with potentially variable endotoxin levels.
4 products
2 recalls
Karl Storz Flexible Hystero-Fiberscope Kits
Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.
1 recall
Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod
The P28 Phantom Intramedullary Nail System guide rod has breaches in its sterile barrier.
2 recalls
BD ChloraPrep Clear
BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.
Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas
Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities risking sterility breach.
2 products
1 recall
Chiesi Cleviprex Clevidipine Injectable Emulsion
Cleviprex injectable emulsion lacks assurance of sterility.
2 recalls
Argon Medical Devices Cardiovascular and Biopsy Trays
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F may not meet sterility release criteria.
6 products
Olympus Evacuators
Some sterilization parameters may not consistently render the devices adequately sterile.
4 products
1 recall
OmniTract Surgical Retractor System
The OmniTract Surgical Retractor System has a dry time that needs to be extended.
1 recall
Boston Scientific Neuromodulation Intracept Access Instruments
Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.
2 recalls
Enovachem Pharmaceuticals Lidocaine HCl Injection
Accucaine kits containing Lidocaine HCl Injection lack assurance of sterility.
2 products
Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses
Sterile tourniquet hoses may have a sterility breach, potentially causing moderate localized infection.
2 products